MAUDE Adverse Event Report: BECTON DICKINSON & CO. / CAREFUSION 2200, INC. CURETTE

Lot Number AP37545

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2021

Event Type  malfunction  

Event Description

A curette handle from the rongeur tray breaks completely in half while md is using on the patient.Md was twisting the instrument and the handle broke.No apparent harm done to the patient.Fda safety report id # (b)(4).

• Brand Name: CURETTE
• Type of Device: CURETTE
• Manufacturer (Section D): BECTON DICKINSON & CO. / CAREFUSION 2200, INC.
• MDR Report Key: 12934893
• MDR Text Key: 281906346
• Report Number: MW5105828
• Device Sequence Number: 1
• Product Code: HTF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: AP37545
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male